ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
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Catalog Number SRF-415 |
Device Problems
Material Rupture (1546); No Apparent Adverse Event (3189)
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Patient Problems
Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2024 |
Event Type
Injury
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Event Description
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Healthcare professional reported, right side rupture.Device remains implanted.
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Manufacturer Narrative
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A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture.
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Event Description
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Healthcare professional later reported "pain post car accident" and is not related to the device.Healthcare professional later reported "grossly intact" and "no evidence intracapsular rupture".
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Search Alerts/Recalls
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